Director Post Market Compliance

Hologic • Marlborough, MA

23h

About The Position

Hologic is a global leader in medical devices and diagnostics dedicated to improving lives through innovative healthcare solutions. The Director of Post Market Compliance, Corporate plays a critical role in ensuring that the company’s systems for managing product and customer concerns are effective, compliant, and continuously improving. This role leads corporate oversight of complaint handling, post market surveillance, medical device reporting, vigilance, and field actions while collaborating with global teams to maintain regulatory compliance and enhance product quality.

Requirements

• Bachelor’s Degree in business, engineering, science, or a related discipline, or equivalent experience.
• Minimum of 10 years of progressive experience in quality assurance within the medical device industry.
• Proven experience managing post market processes such as complaints, vigilance, and field actions.
• Demonstrated success in managing audits in FDA-regulated cGMP facilities.
• Experience leading teams, managing projects, and building a strong culture of quality.
• Deep understanding of medical device regulatory requirements and compliance standards across domestic and international markets.
• Knowledge of complaint handling, post market surveillance, medical device reporting, vigilance, and field action processes.
• Familiarity with FDA-regulated cGMP environments and audit requirements.
• Understanding of quality management systems and electronic complaint/quality record systems.
• Awareness of emerging regulatory changes and their impact on post market processes.
• Strong leadership and stakeholder management skills with the ability to influence cross-functional and international teams.
• Strategic and analytical thinking to translate corporate goals into actionable plans.
• Effective communication and reporting skills for presenting performance metrics and quality insights to senior leadership.
• Strong accountability for regulatory compliance and product quality.
• Collaborative and proactive in working with multiple departments including service, IS, and international teams.
• Results-driven mindset focused on continuous improvement and operational efficiency.
• Strong problem-solving approach when identifying compliance gaps and implementing corrective actions.

Responsibilities

• Leads corporate oversight of complaint handling, post market surveillance, medical device reporting, vigilance, and field actions.
• Collaborates with global teams to maintain regulatory compliance and enhance product quality.
• Drives process improvements through project and program management capabilities.
• Identifies trends and improvement opportunities using data analysis skills with quality data management tools.
• Presents performance metrics and quality insights to senior leadership.
• Fosters a culture of quality and transparency across the organization.

Benefits

• Comprehensive training when you join
• Continued development and training throughout your career
• Bonus eligible

What This Job Offers

• Job Type: Full-time
• Career Level: Director